Eligibility Criteria

Please answer the following questions to see if you may be eligible to participate in the KEYNOTE695 study. When you are ready, click AM I ELIGIBLE?

A complete list of eligibility criteria can be found online at ClinicalTrials.gov

For specific questions related to your eligibility for a clinical trial we encourage you to contact patientinfo@oncosec.com

About the Study

KEYNOTE695 is a Phase 2 clinical trial study of intratumoral tavokinogene telseplasmid (TAVO; pIL-12) Electroporation (EP) plus IV Pembrolizumab for patients with pathological diagnosis of unresectable or metastatic melanoma who are progressing or have progressed on pembrolizumab.

TAVO is DNA-based interleukin-12 (IL-12; TAVO), a naturally occurring protein with immune-stimulating functions. IL-12 is an investigational treatment that has not been approved by the U.S. Food and Drug Administration (FDA) for melanoma or any other disease. The process is designed to produce a controlled, localized expression of TAVO in the tumor microenvironment, which in turn, enables the immune system to target and attack tumors throughout the body.

Pembrolizumab, delivered by IV infusion, is a medication that has been approved by the FDA for the treatment of metastatic melanoma. Pembrolizumab is a type of immunotherapy that works by targeting PD-1, a signaling receptor that helps cancer cells hide from the body’s immune system. Pembrolizumab blocks the PD-1 pathway and helps the immune system target and fight cancer cells.

It is believed that the combination will provide more effective response in the body and that will affect tumor growth.

1IL-12 = tavokinogene telseplasmid (TAVO) TAVO

2Reference SITC 2017

STATUS

Active and recruiting participants

PATIENT GOAL

100

TRIAL PHASE

Phase 2 Registration-Directed Open Label Clinical Trial.

Participants will receive a study treatment of intratumoral tavokinogene telseplasmid (TAVO; pIL-12) in combination with pembrolizumab, which may enhance the effects of the anti-PD-1 therapy allowing the participants immune system to fight and detect cancer cells.

  • The study will be comprised of a screening period, a treatment period (up to 2 years) and a long-term follow-up.
  • Eligible patients will be treated with intratumoral TAVO-EP to the accessible lesions on Days 1, 5 and 8 every 6 weeks and with IV pembrolizumab (200mg) on Day 1 of each 3-week cycle for 17 TAVO-EP cycles and 33 pembrolizumab cycles (from baseline) of continued treatment (approximately 2 years), or until disease progression. As many accessible lesions may be treated as deemed feasible by the treating physician assuming the size of each lesion is greater than 0.3 cm x 0.3 cm.
  • Long-Term Follow-Up: All subjects will be followed after End of Study (EOS) visit for SAEs (through 90 days from last dose of study drug) and long-term survival status. EOS visit will occur 4 weeks after last study treatment administration.

Patients will receive treatment in a two-step process:

  • A needle is used to inject the human gene IL-12 (tavo)1 directly into the tumor;
  • Followed by a small electrical current (electroporation) to allow the IL-12 gene to readily enter the tumor, every 6 weeks, for the duration of the study.
  • There is a 30-minute infusion of pembrolizumab once every three weeks.

Tests and procedures during this study include:

  • Ongoing measurements and imaging of melanoma lesions, physical exams, and samples of blood, tissue, stool and tumor biopsies for the immune monitoring program.
  • Data analyzed from these samples will allow for a deeper understanding of how to best fight cancer in this and future clinical trials.

1IL-12 = tavokinogene telseplasmid

There are professional services and information to assist people navigate the practical, emotional and financial challenges of cancer.

Advocacy Pan-Tumor Cancer Orgs:

Melanoma Advocacy Orgs:

Care-Partner Resources:

Financial & Transportation Resource Information:

This study will be conducted in the following sites across the United States and Australia.

To learn more about how to contact a study site, please email patientinfo@oncosec.com.

      Q: Who is involved in clinical research studies?
      A: This clinical research study is supported by doctors, nurses, and other healthcare professionals. The commitment of each participant and the entire study team is important to help meet the objectives of the study. This study follows strict ethical and governmental guidelines to ensure that participants’ rights are protected while the information is being collected.

      Q: How long will I take part in this study?
      A: The study will be comprised of a screening period, a treatment period (up to 2 years) and a long-term follow-up. Eligible patients will be treated with intratumoral TAVO-EP to the accessible lesions on Days 1, 5 and 8 every 6 weeks and with IV pembrolizumab (200mg) on Day 1 of each 3-week cycle for 17 TAVO EP cycles and 33 pembrolizumab cycles (from baseline) of continued treatment (approximately 2 years), or until disease progression. As many accessible lesions may be treated as deemed feasible by the treating physician assuming the size of each lesion is greater than 0.3 cm x 0.3 cm.

      Q: What happens if I leave the study?
      A: You are free to leave the study at any point. Leaving the study will not impact your care.

      Q: What will happen to my data?
      A: Data will be collected, handled, and processed in compliance with applicable regulation guidelines. It will not be shared with anyone other than in circumstances that will be explained in your consent form.

      Q: Will my data identify me?
      A: Your identity will not be available to the company sponsoring this clinical trial or any of their research partners.

      To learn more about this study or to reach a study site, please contact: patientinfo@oncosec.com

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